Biosimilarity of Recombinant Human EPO Products from CHO Cell Lines: A Carbohydrate Structural View View Full Text


Ontology type: schema:Chapter     


Chapter Info

DATE

2010-06-02

AUTHORS

Nicolas Grammel , Frank Dittrich , Sebastian Kandzia , Eckart Grabenhorst , Harald S. Conradt

ABSTRACT

The detailed knowledge of the N- and O-linked oligosaccharides of recombinantly produced human glycoprotein therapeutics is a prerequisite for their use in patients. From the regulatory point of view (EMEA, FDA), the carbohydrates of therapeutic glycoproteins (e.g. EPO, IFN-ß, therapeutic antibodies) play a key role in efficacy and safety (e.g. immunogenicity).In the present work we show that by using ESI-TOF-MS analysis of entire EPO preparations after desialylation or after removal of N-linked oligosaccharides, exact mass determination of glycoprotein variants can be achieved, thus enabling its application in the lot-to-lot consistency control of the final product as well as during cell line and product development.Moreover, ESI-TOF-MS of subfractions of oligosaccharide mixtures obtained from enzymatically liberated glycans after IEX chromatography enabled detailed structural assignments of the total oligosaccharide mixtures derived from pharmaceutical glycoproteins. More... »

PAGES

861-865

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/978-90-481-3419-9_151

DOI

http://dx.doi.org/10.1007/978-90-481-3419-9_151

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1019463355


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/06", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Biological Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/0601", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Biochemistry and Cell Biology", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "GlycoThera GmbH, Inhoffenstr.7, 38124, Braunschweig, Germany", 
          "id": "http://www.grid.ac/institutes/None", 
          "name": [
            "GlycoThera GmbH, Inhoffenstr.7, 38124, Braunschweig, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Grammel", 
        "givenName": "Nicolas", 
        "id": "sg:person.01047362710.01", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01047362710.01"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "GlycoThera GmbH, Inhoffenstr.7, 38124, Braunschweig, Germany", 
          "id": "http://www.grid.ac/institutes/None", 
          "name": [
            "GlycoThera GmbH, Inhoffenstr.7, 38124, Braunschweig, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Dittrich", 
        "givenName": "Frank", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "GlycoThera GmbH, 38124, Braunschweig, Germany", 
          "id": "http://www.grid.ac/institutes/None", 
          "name": [
            "GlycoThera GmbH, 38124, Braunschweig, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Kandzia", 
        "givenName": "Sebastian", 
        "id": "sg:person.01115476110.75", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01115476110.75"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "GlycoThera GmbH, 38124, Braunschweig, Germany", 
          "id": "http://www.grid.ac/institutes/None", 
          "name": [
            "GlycoThera GmbH, 38124, Braunschweig, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Grabenhorst", 
        "givenName": "Eckart", 
        "id": "sg:person.01313334742.81", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01313334742.81"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "GlycoThera GmbH, 38124, Braunschweig, Germany", 
          "id": "http://www.grid.ac/institutes/None", 
          "name": [
            "GlycoThera GmbH, 38124, Braunschweig, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Conradt", 
        "givenName": "Harald S.", 
        "id": "sg:person.01346153110.13", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01346153110.13"
        ], 
        "type": "Person"
      }
    ], 
    "datePublished": "2010-06-02", 
    "datePublishedReg": "2010-06-02", 
    "description": "The detailed knowledge of the N- and O-linked oligosaccharides of recombinantly produced human glycoprotein therapeutics is a prerequisite for their use in patients. From the regulatory point of view (EMEA, FDA), the carbohydrates of therapeutic glycoproteins (e.g. EPO, IFN-\u00df, therapeutic antibodies) play a key role in efficacy and safety (e.g. immunogenicity).In the present work we show that by using ESI-TOF-MS analysis of entire EPO preparations after desialylation or after removal of N-linked oligosaccharides, exact mass determination of glycoprotein variants can be achieved, thus enabling its application in the lot-to-lot consistency control of the final product as well as during cell line and product development.Moreover, ESI-TOF-MS of subfractions of oligosaccharide mixtures obtained from enzymatically liberated glycans after IEX chromatography enabled detailed structural assignments of the total oligosaccharide mixtures derived from pharmaceutical glycoproteins.", 
    "editor": [
      {
        "familyName": "Noll", 
        "givenName": "Thomas", 
        "type": "Person"
      }
    ], 
    "genre": "chapter", 
    "id": "sg:pub.10.1007/978-90-481-3419-9_151", 
    "inLanguage": "en", 
    "isAccessibleForFree": false, 
    "isPartOf": {
      "isbn": [
        "978-90-481-3418-2", 
        "978-90-481-3419-9"
      ], 
      "name": "Cells and Culture", 
      "type": "Book"
    }, 
    "keywords": [
      "ESI-TOF", 
      "detailed structural assignments", 
      "exact mass determination", 
      "oligosaccharide mixtures", 
      "structural assignment", 
      "IEX chromatography", 
      "MS analysis", 
      "final product", 
      "liberated glycans", 
      "mass determination", 
      "glycoprotein therapeutics", 
      "therapeutic glycoproteins", 
      "mixture", 
      "EPO products", 
      "present work", 
      "products", 
      "chromatography", 
      "oligosaccharides", 
      "glycoprotein variants", 
      "pharmaceutical glycoproteins", 
      "preparation", 
      "MS", 
      "determination", 
      "structural view", 
      "detailed knowledge", 
      "removal", 
      "glycans", 
      "EPO preparations", 
      "assignment", 
      "carbohydrates", 
      "key role", 
      "applications", 
      "therapeutics", 
      "work", 
      "biosimilarity", 
      "glycoprotein", 
      "cell lines", 
      "analysis", 
      "subfractions", 
      "product development", 
      "prerequisite", 
      "use", 
      "desialylation", 
      "lines", 
      "development", 
      "point", 
      "view", 
      "role", 
      "consistency control", 
      "CHO cell lines", 
      "efficacy", 
      "control", 
      "regulatory point", 
      "knowledge", 
      "safety", 
      "variants", 
      "patients", 
      "human glycoprotein therapeutics", 
      "entire EPO preparations", 
      "MS of subfractions", 
      "total oligosaccharide mixtures", 
      "Recombinant Human EPO Products", 
      "Human EPO Products", 
      "Carbohydrate Structural View"
    ], 
    "name": "Biosimilarity of Recombinant Human EPO Products from CHO Cell Lines: A Carbohydrate Structural View", 
    "pagination": "861-865", 
    "productId": [
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1019463355"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1007/978-90-481-3419-9_151"
        ]
      }
    ], 
    "publisher": {
      "name": "Springer Nature", 
      "type": "Organisation"
    }, 
    "sameAs": [
      "https://doi.org/10.1007/978-90-481-3419-9_151", 
      "https://app.dimensions.ai/details/publication/pub.1019463355"
    ], 
    "sdDataset": "chapters", 
    "sdDatePublished": "2021-11-01T18:50", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-springernature-scigraph/baseset/20211101/entities/gbq_results/chapter/chapter_215.jsonl", 
    "type": "Chapter", 
    "url": "https://doi.org/10.1007/978-90-481-3419-9_151"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/978-90-481-3419-9_151'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/978-90-481-3419-9_151'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/978-90-481-3419-9_151'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/978-90-481-3419-9_151'


 

This table displays all metadata directly associated to this object as RDF triples.

153 TRIPLES      23 PREDICATES      89 URIs      82 LITERALS      7 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1007/978-90-481-3419-9_151 schema:about anzsrc-for:06
2 anzsrc-for:0601
3 schema:author N0866d532f8dd417993e49efb25623331
4 schema:datePublished 2010-06-02
5 schema:datePublishedReg 2010-06-02
6 schema:description The detailed knowledge of the N- and O-linked oligosaccharides of recombinantly produced human glycoprotein therapeutics is a prerequisite for their use in patients. From the regulatory point of view (EMEA, FDA), the carbohydrates of therapeutic glycoproteins (e.g. EPO, IFN-ß, therapeutic antibodies) play a key role in efficacy and safety (e.g. immunogenicity).In the present work we show that by using ESI-TOF-MS analysis of entire EPO preparations after desialylation or after removal of N-linked oligosaccharides, exact mass determination of glycoprotein variants can be achieved, thus enabling its application in the lot-to-lot consistency control of the final product as well as during cell line and product development.Moreover, ESI-TOF-MS of subfractions of oligosaccharide mixtures obtained from enzymatically liberated glycans after IEX chromatography enabled detailed structural assignments of the total oligosaccharide mixtures derived from pharmaceutical glycoproteins.
7 schema:editor N6fa5010f1bc94152abe0cdc9408e69c6
8 schema:genre chapter
9 schema:inLanguage en
10 schema:isAccessibleForFree false
11 schema:isPartOf N272ce0a794554b618e68032f054f51e8
12 schema:keywords CHO cell lines
13 Carbohydrate Structural View
14 EPO preparations
15 EPO products
16 ESI-TOF
17 Human EPO Products
18 IEX chromatography
19 MS
20 MS analysis
21 MS of subfractions
22 Recombinant Human EPO Products
23 analysis
24 applications
25 assignment
26 biosimilarity
27 carbohydrates
28 cell lines
29 chromatography
30 consistency control
31 control
32 desialylation
33 detailed knowledge
34 detailed structural assignments
35 determination
36 development
37 efficacy
38 entire EPO preparations
39 exact mass determination
40 final product
41 glycans
42 glycoprotein
43 glycoprotein therapeutics
44 glycoprotein variants
45 human glycoprotein therapeutics
46 key role
47 knowledge
48 liberated glycans
49 lines
50 mass determination
51 mixture
52 oligosaccharide mixtures
53 oligosaccharides
54 patients
55 pharmaceutical glycoproteins
56 point
57 preparation
58 prerequisite
59 present work
60 product development
61 products
62 regulatory point
63 removal
64 role
65 safety
66 structural assignment
67 structural view
68 subfractions
69 therapeutic glycoproteins
70 therapeutics
71 total oligosaccharide mixtures
72 use
73 variants
74 view
75 work
76 schema:name Biosimilarity of Recombinant Human EPO Products from CHO Cell Lines: A Carbohydrate Structural View
77 schema:pagination 861-865
78 schema:productId N6b18d25dff6f4d1880014d71eada8b4b
79 Nd940584aec5343c58ddd7818f674069d
80 schema:publisher N36a7c327da4f457d917ddf33d9995e36
81 schema:sameAs https://app.dimensions.ai/details/publication/pub.1019463355
82 https://doi.org/10.1007/978-90-481-3419-9_151
83 schema:sdDatePublished 2021-11-01T18:50
84 schema:sdLicense https://scigraph.springernature.com/explorer/license/
85 schema:sdPublisher Nbd727a8deee04eeca93e5f4d33fc9c79
86 schema:url https://doi.org/10.1007/978-90-481-3419-9_151
87 sgo:license sg:explorer/license/
88 sgo:sdDataset chapters
89 rdf:type schema:Chapter
90 N0866d532f8dd417993e49efb25623331 rdf:first sg:person.01047362710.01
91 rdf:rest Nf38c1bf957944220aa1f5a3052b45bac
92 N15c7afc417154de8a90140365e85f12d rdf:first sg:person.01115476110.75
93 rdf:rest N3694afd5d5464be7a7cfa750b68d1b6c
94 N272ce0a794554b618e68032f054f51e8 schema:isbn 978-90-481-3418-2
95 978-90-481-3419-9
96 schema:name Cells and Culture
97 rdf:type schema:Book
98 N3694afd5d5464be7a7cfa750b68d1b6c rdf:first sg:person.01313334742.81
99 rdf:rest N6873acabcc6e4231a770cc96bd9e8a37
100 N36a7c327da4f457d917ddf33d9995e36 schema:name Springer Nature
101 rdf:type schema:Organisation
102 N6873acabcc6e4231a770cc96bd9e8a37 rdf:first sg:person.01346153110.13
103 rdf:rest rdf:nil
104 N6b18d25dff6f4d1880014d71eada8b4b schema:name doi
105 schema:value 10.1007/978-90-481-3419-9_151
106 rdf:type schema:PropertyValue
107 N6fa5010f1bc94152abe0cdc9408e69c6 rdf:first Nd4965c705007425f91db35c8a4c28b69
108 rdf:rest rdf:nil
109 Na14ecb97e78e4ad8911d69638e225e27 schema:affiliation grid-institutes:None
110 schema:familyName Dittrich
111 schema:givenName Frank
112 rdf:type schema:Person
113 Nbd727a8deee04eeca93e5f4d33fc9c79 schema:name Springer Nature - SN SciGraph project
114 rdf:type schema:Organization
115 Nd4965c705007425f91db35c8a4c28b69 schema:familyName Noll
116 schema:givenName Thomas
117 rdf:type schema:Person
118 Nd940584aec5343c58ddd7818f674069d schema:name dimensions_id
119 schema:value pub.1019463355
120 rdf:type schema:PropertyValue
121 Nf38c1bf957944220aa1f5a3052b45bac rdf:first Na14ecb97e78e4ad8911d69638e225e27
122 rdf:rest N15c7afc417154de8a90140365e85f12d
123 anzsrc-for:06 schema:inDefinedTermSet anzsrc-for:
124 schema:name Biological Sciences
125 rdf:type schema:DefinedTerm
126 anzsrc-for:0601 schema:inDefinedTermSet anzsrc-for:
127 schema:name Biochemistry and Cell Biology
128 rdf:type schema:DefinedTerm
129 sg:person.01047362710.01 schema:affiliation grid-institutes:None
130 schema:familyName Grammel
131 schema:givenName Nicolas
132 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01047362710.01
133 rdf:type schema:Person
134 sg:person.01115476110.75 schema:affiliation grid-institutes:None
135 schema:familyName Kandzia
136 schema:givenName Sebastian
137 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01115476110.75
138 rdf:type schema:Person
139 sg:person.01313334742.81 schema:affiliation grid-institutes:None
140 schema:familyName Grabenhorst
141 schema:givenName Eckart
142 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01313334742.81
143 rdf:type schema:Person
144 sg:person.01346153110.13 schema:affiliation grid-institutes:None
145 schema:familyName Conradt
146 schema:givenName Harald S.
147 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01346153110.13
148 rdf:type schema:Person
149 grid-institutes:None schema:alternateName GlycoThera GmbH, 38124, Braunschweig, Germany
150 GlycoThera GmbH, Inhoffenstr.7, 38124, Braunschweig, Germany
151 schema:name GlycoThera GmbH, 38124, Braunschweig, Germany
152 GlycoThera GmbH, Inhoffenstr.7, 38124, Braunschweig, Germany
153 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...